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Later Stage Trials
Biomarkers: Enrich or Stratify?
•
Enrich = “integral”
–
Certainty about
biomarker
–
Certainty that you do not
wish to test others
–
Assay clinically valid
(FDA is watching you!)
•
Stratify = “integrated”
–
Bigger than no-biomarker
trial
–
Assay clinically valid (less
scrutiny)